Study Evaluating The Safety Of Xyntha In Usual Care Settings

Phase 4TerminatedNCT00765726

Pfizer12 enrolled

Overview

The purpose of this study is to collect safety information associated with the use of Xyntha in a usual care setting. Upon meeting eligibility criteria, patients will be required to have approximately 5 study visits over a 2 year period. Procedures completed throughout the study include collection of vital signs, physical exams, and laboratory assessments. Patients will be required to complete an infusion log for each Xyntha infusion.

The study was terminated on May 12, 2011 due to poor enrollment prospects and the study's similarity to another ongoing trial with ReFacto AF. The termination of this study has no impact on subject safety or well being. The decision to terminate the trial was not based on any safety concerns.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hemophilia A

Interventions

Moroctocog alfa(AF-CC)BIOLOGICAL

Dosing is at the discretion of the investigator during the study

Blood draw for laboratory testingPROCEDURE

Hematology and Chemistry panels, Factor VIII inhibitor and recovery studies

Eligibility

Sex: MALEMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients 12 years of age and older. * Patients transitioned to Xyntha from other recombinant or plasma-derived FVIII replacement products. * Treatment history of 150 or greater exposure days to any FVIII products prior to Enrollment visit. * Negative inhibitor at screening or documentation of negative inhibitor titer within 6 weeks or less prior to study entry except for patients entering the study on immune tolerance induction therapy. Exclusion Criteria: * Bleeding disorder other than hemophilia A. * Inhibitor titer greater than or equal to 0.6 BU during screening except for patients on immune tolerance induction therapy. * Immunomodulatory therapy during screening period. * Known hypersensitivity to hamster protein.

Locations (6)

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Washington D.C., District of Columbia, United States

Pfizer Investigational Site

Detroit, Michigan, United States

Pfizer Investigational Site

East Lansing, Michigan, United States

Outcomes

Primary Outcomes

Percentage of Participants With Factor VIII (FVIII) Inhibitor Development

FVIII inhibitor development was defined as an inhibitor titer of more than or equal to 0.6 Bethesda Units (BU) using the Nijmegen modification of the Bethesda assay and confirmed by the central laboratory.

Time frame: Month 24 or early withdrawal

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.